盐酸纳布啡注射液用于剖宫产术后镇痛的临床研究及其对产后抑郁的预防作用

Clinical trial of nalbuphine hydrochloride injection on analgesia after cesarean section and its preventive effect on postpartum depression

目的观察盐酸纳布啡注射液用于剖宫产术后镇痛的临床疗效和安全性,及其对产后抑郁的预防作用。方法将400例剖宫产手术的足月妊娠产妇随机分为A、B、C、D组,每组100例。A组术后予以舒芬太尼100μg,静脉自控镇痛;B组术后予以盐酸纳布啡1.5 mg·kg-1,静脉自控镇痛;C组术后予以盐酸纳布啡2.0 mg·kg-1,静脉自控镇痛;D组术后予以盐酸纳布啡2.5 mg·kg^(-1),静脉自控镇痛。比较4组产妇术后6,12,24 h的视觉模拟评分法(VAS)和Ramsay镇静评分法(RSS)评分、抑郁状况,以及药物不良反应的发生情况。结果术后6,12,24 h,A组的VAS评分分别为(3.21±0.44),(3.15±0.49),(2.06±0.49)分,RSS评分分别为(2.08±0.37),(2.05±0.35),(1.85±0.23)分;B组的VAS评分分别为(2.17±0.35),(2.00±0.38),(1.45±0.38)分,RSS评分分别为(2.01±0.19),(1.91±0.21),(1.72±0.18)分;C组的VAS评分分别为(2.08±0.22),(1.53±0.26),(0.75±0.13)分,RSS评分分别为(1.71±0.15),(1.75±0.12),(1.46±0.15)分;D组的VAS评分分别为(2.10±0.21),(1.52±0.21),(0.72±0.11)分,RSS评分分别为(1.64±0.22),(1.62±0.15),(1.43±0.21)分,在不同时间点C、D组的VAS评分和RSS评分与A、B组比较,差异均有统计学意义(均P<0.05)。产后3 d,A、B、C、D组的抑郁率分别为35.00%(35/100例),27.00%(27/100例),12.00%(12/100例),26.00%(26/100例),C组与A、B、D组比较,差异均有统计学意义(均P<0.05)。A组的药物不良反应主要有心率下降、恶性呕吐、腹泻、皮疹,B、C组的药物不良反应主要有心跳过快、恶心呕吐、尿潴留,D组的药物不良反应主要有心跳过快、恶心呕吐、腹泻、皮疹。A、B、C、D组药物不良反应发生率为14.00%,10.00%,11.00%,21.00%,D组与A、B、C组间相互比较差异均有统计学意义(均P<0.05)。结论盐酸纳布啡2.0 mg·kg-1对剖宫产术后的镇痛、镇静效果显著,且产后抑郁率和药物不良反应发生率较低。

Objective To observe the clinical efficacy and safety of nal- buphine hydrochloride injection on cesarean section analgesia and its pre- ventive effect on postpartum depression. Methods A total of 400 term pregnancy maternal with cesarean section were randomly divided into groups A, B, C, D with 100 cases per group. Group A was treated with sufentanil 100 μg. Groups B, C, D were treated with hydrochloric nalbu- phine 1.5, 2.0 and 2. 5 mg· kg^-1, respectively. Four groups received patient- controlled intravenous analgesia. The visual analogue scale （VAS） and Ramsay sedation scores （RSS） of 6,12,24 h after operation, depression status and adverse drug reactions were compared between four groups. Results 6,12,24 h after operation, in group A, VAS were （3.21± 0. 44）, （3.15 ± 0. 49 ）, （2.06 ± 0. 49） points, RSS were （ 2. 08 ± 0. 37 ）, （ 2.05 ±0. 35 ）, （ 1.85 ± 0. 23 ） points ; in group B, VAS were （2. 17 ±0.35）, （2.00 ±0.38）, （1.45 ±0. 38）points, RSS were （2.01 ±0. 19）, （1.91 ±0.21）, （ 1.72 ±0. 18 ） points ; in group C, VAS were （2.08 ±0.22）, （ 1.53 ± 0.26）, （0.75 ±0. 13 ） points, RSS were （1.71±0.15）, （1.75 ±0.12）, （1.46±0.15）points; in group D, VAS were （2.10±0.21）, （1.52±0.21）, （0. 72 ±0. 11 ） points, RSS were （ 1.64±0. 22 ）, （ 1.62 ±0. 15 ）, （ 1.43 ± 0. 21 ） points, there were significant differences in VAS score and RSS score at different times between groups C, D and groups A, B （ P 〈 0.05 ）. 3 d postpartum, the depression rates in groups A, B, C, D were 35.00% （35/100 cases）, 27.00% （27/100 cases）, 12. 00% （ 12/100 cases）, 26. 00% （26/100 cases）, with significant differences between group C and groups A, B, D （P 〈 0. 05）. The adverse drug reactions in group A were heart rate, vomiting, diarrhea and rash, which in group B and C were rapid heartbeat, nausea, vomiting and urinary retention, in group D were rapid heartbeat, nausea, vomiting, diarrhea and rash. The incidences of adverse drug reactions were 14.00%, 10. 00%, 11.00%, 21.00%, with significant differences between group D and groups A, B, C （P 〈 0. 05 ）. Conclusion Nalbuphine 2. 0 mg·kg^-1 has a definitive clinical efficacy on analgesic and sedative after cesarean section, with low postpartum depression rate and adverse reactions rate.